5.2.1 Procedures for assessing, recording and reporting SAEs All SAEs must be reported by facsimile or electronic transmission to the study's medical monitor within 24 hours after the onset of the SAE (or the awareness of the investigator of the event). The study's medical monitor then notifies the study PI of the SAE within one working day after receiving the report from a clinical site. In addition, a clinical site must report a death or life-threatening event by telephone as soon as possible and within 24 hours to the study's medical monitor.